Z-0092-2024Class II

Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile

Name: Z-0092-2024 Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile
Creator: Cardinal Health 200, LLC
Published: 2023-08-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-08-16 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile on 2023-08-16. FDA classified it as Class II and gives the reason as "Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0092-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-16
Posted: 2023-10-10
Recalling firm: Medtronic, Inc.
Product: Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.
Product code: OIP Radiology-Diagnostic Kit
Reason for recall: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The recalling firm issued letters dated 8/17/2023 via overnight mail on 8/16/2023. The letter explained the reason for recall, risk to health, and the actions required and included a copy of the supplier's letter. The actions were for the consignee to (1) review their inventory for the affected catalog and lot numbers in the enclosed attachment; (2) segregate and quarantine the affected product and follow instructions in the letter for product return; (3)notify any customers to whom they may have distributed/forwarded the affected product and share a copy of the recall letter to notify them; and (4) return the enclosed acknowledgment form via FAX or email as to whether they have the affected product. Instructions for contacting the appropriate Customer Service groups are provided to arrange for return and credit/replacement of the affected product. An example of a label is provided to show where to find the catalog number, lot number, and expiration date.
Quantity in commerce: 13,351 total packs
Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.
Product codes and lots: Lot #23520, Exp. 2/1/2025, UDI-DI 10888439920840.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0092-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0083-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-10
Z-0084-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-10
Z-0085-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-10
Z-0086-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-10
Z-0087-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-10
Z-0088-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-10
Z-0089-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-10
Z-0090-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-10
Z-0091-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-10
Z-0092-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-10

Product code OIP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)